Iopidine Eye

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/27/2022

Drug Summary

What Is Iopidine Eye?

Iopidine 0.5% (apraclonidine) is an alpha-adrenergic agonist, which decreases the amount of fluid in the eye, decreasing pressure in the eye, used to treat or prevent high pressure inside the eye caused by certain types of eye surgery or procedures. Iopidine 0.5% is available in generic form.

What Are Side Effects of Iopidine Eye?

Common side effects of Iopidine 0.5% include:

  • eye discomfort/redness/burning/dryness,
  • blurred or dimmed vision,
  • feeling like something is in your eye,
  • dry mouth,
  • dry or stuffy nose,
  • dizziness,
  • drowsiness,
  • stomach pain or upset,
  • nausea,
  • diarrhea,
  • headache,
  • sleep problems (insomnia), or
  • unusual tiredness.

Eye itching or watering, or eyelid swelling or puffiness may be symptoms of an allergic reaction of the eye. Tell your doctor if you have unlikely but serious side effects of Iopidine 0.5% including:

  • mental/mood changes (e.g., depression, irritability), or
  • slow or irregular heartbeat.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Iopidine Eye

The dose of Iopidine Ophthalmic Solution is one to two drops instilled in the affected eye(s) three times daily.

What Drugs, Substances, or Supplements Interact with Iopidine Eye?

Since Iopidine will be used with other ocular glaucoma therapies, wait at least 5 minutes between uses of each medication. Iopidine may interact with blood pressure medications, or heart rhythm medication. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Iopidine Eye During Pregnancy or Breastfeeding

During pregnancy, Iopidine should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Iopidine 0.5% (apraclonidine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Drug Description


IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off-white powder and is highly soluble in water. Its chemical name is 2-[(4-amino-2,6 dichlorophenyl)imino] imidazolidine monohydrochloride with an empirical formula of C9H11Cl3N4 and a molecular weight of 281.6.

The chemical structure of apraclonidine hydrochloride is:

IOPIDINE* 1% (apraclonidine hydrochloride) Structural Formula Illustration

Each mL of IOPIDINE 1% Ophthalmic Solution contains: Actives: apraclonidine hydrochloride 11.5 mg equivalent to apraclonidine base 10 mg. Inactives: sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4-7.8), purified water and benzalkonium chloride 0.01% (preservative). Osmolality is 260-320 mOsm.

Indications & Dosage


IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.


One drop of IOPIDINE* 1% Ophthalmic Solution should be instilled in the scheduled operative eye one hour before initiating anterior segment laser surgery and a second drop should be instilled to the same eye immediately upon completion of the laser surgical procedure. Use a separate container for each single-drop dose and discard each container after use.


Storage And Handling

IOPIDINE 1% Ophthalmic Solution as base is a sterile, isotonic, aqueous solution containing apraclonidine hydrochloride. Supplied as follows: 0.1 mL in plastic ophthalmic dispensers, packaged two per pouch. These dispensers are enclosed in a foil overwrap as an added barrier to evaporation.

0.1 mL (packaged two per pouch) NDC 0065-0660-10


Store at 2°C to 25°C (36°F-77°F).

Protect from light.

Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA. Revised: Mar 2018.

Warnings & Precautions


FOR TOPICAL OPHTHALMIC USE ONLY. Not for injection or oral ingestion.



Since IOPIDINE* 1% Ophthalmic Solution is a potent depressor of IOP, patients who develop exaggerated reductions in IOP should be closely monitored. Although the acute administration of two drops of IOPIDINE 1% Ophthalmic Solution has minimal effect on heart rate or blood pressure in clinical studies evaluating patients undergoing anterior segment laser surgery, the preclinical pharmacologic profile of this drug suggests that caution should be observed in treating patients with severe cardiovascular disease including hypertension. IOPIDINE 1% Ophthalmic Solution should also be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, chronic renal failure, Raynaud’s disease or thromboangiitis obliterans.

The possibility of a vasovagal attack occurring during laser surgery should be considered and caution used in patients with history of such episodes.

Topical ocular administration of two drops of 0.5%, 1%, and 1.5% IOPIDINE Ophthalmic Solution to New Zealand Albino rabbits three times daily for one month resulted in sporadic and transient instances of minimal corneal cloudiness in the 1.5% group only. No histopathological changes were noted in those eyes. No adverse ocular effects were observed in cynomolgus monkeys treated with two drops of 1.5% IOPIDINE Ophthalmic Solution applied three times daily for three months. No corneal changes were observed in 320 humans given at least one dose of IOPIDINE 1% Ophthalmic Solution.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No significant change in tumor incidence or type was observed following two years of oral administration of apraclonidine HCl to rats and mice at dosages of 1 and 0.6 mg/kg/day, up to 50 and 30 times, respectively, the maximum dose recommended for human topical ocular use. Apraclonidine HCl was not mutagenic in a series of in vitro mutagenicity tests, including the Ames test, a mouse lymphoma forward mutation assay, a chromosome aberration assay in cultured Chinese hamster ovary (CHO) cells, a sister chromatid exchange assay in CHO cells, and a cell transformation assay. An in vivo mouse micronucleus assay conducted with apraclonidine HCl also provided no evidence of mutagenicity. Reproduction and fertility studies in rats showed no adverse effect on male or female fertility at a dose of 0.5 mg/kg/day (25 times the maximum recommended human dose).


Apraclonidine HCl has been shown to have an embryocidal effect in rabbits when given in an oral dose of 3 mg/kg/day (150 times the maximum recommended human dose). Dose related maternal toxicity was observed in pregnant rats at 0.3 mg/kg/day (15 times the maximum recommended human dose). There are no adequate and well controlled studies in pregnant women. IOPIDINE* 1% Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known if topically applied IOPIDINE 1% Ophthalmic Solution is excreted in human milk. Decision should be made to discontinue nursing temporarily for the one day on which IOPIDINE 1% Ophthalmic Solution is used.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Overdose & Contraindications


Ingestion of IOPIDINE* 0.5% Ophthalmic Solution has been reported to cause bradycardia, drowsiness, and hypothermia. Accidental or intentional ingestion of oral clonidine has been reported to cause apnea, arrhythmias, asthenia, bradycardia, conduction defects, diminished or absent reflexes, dryness of the mouth, hypotension, hypothermia, hypoventilation, irritability, lethargy, miosis, pallor, respiratory depression, sedation or coma, seizure, somnolence, transient hypertension, and vomiting. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. Hemodialysis is of limited value since a maximum of 5% of circulating drug is removed.


IOPIDINE 1% Ophthalmic Solution is contraindicated for patients receiving monoamine oxidase inhibitor therapy and for patients with hypersensitivity to any component of this medication or to clonidine.

Clinical Pharmacology


Apraclonidine is a relatively selective, alpha adrenergic agonist and does not have significant membrane stabilizing (local anesthetic) activity. When instilled intothe eye, IOPIDINE 1% (apraclonidine hydrochloride ophthalmic solution) has the action of reducing intraocular pressure. Ophthalmic apraclonidine has minimal effect on cardiovascular parameters.

Optic nerve head damage and visual field loss may result from an acute elevation in intraocular pressure that can occur after argon or Nd:YAG laser surgical procedures.Elevated intraocular pressure, whether acute or chronic in duration, is a major risk factor in the pathogenesis of visual field loss. The higher the peak or spike of intraocular pressure, the greater the likelihood of visual field loss and optic nerve damage especially in patients with previously compromised optic nerves. The onset of action with IOPIDINE 1% Ophthalmic Solution can usually be noted within one hour and the maximum intraocular pressure reduction usually occurs three to five hours after application of a single dose. The precise mechanism of the ocular hypotensive action of IOPIDINE 1% Ophthalmic Solution is not completely established at this time. Aqueous fluorophotometry studies in man suggest that its predominant action may be related to a reduction of aqueous formation. Controlled clinical studies of patients requiring argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy showed that IOPIDINE 1% Ophthalmic Solution controlled or prevented the post-surgical intraocular pressure rise typically observed in patients after undergoing those procedures. After surgery, the mean intraocular pressure was 1.2 to 4 mmHg below the corresponding pre-surgical baseline pressure before IOPIDINE Ophthalmic Solution treatment. With placebo treatment, post-surgical pressures were 2.5 to 8.4 mmHg higher than their corresponding pre-surgical baselines.

Overall, only 2% of patients treated with IOPIDINE* 1% Ophthalmic Solution had severe intraocular pressure elevations (spike≥10 mmHg) during the first three hours after laser surgery, whereas 23% of placebo-treated patients responded with severe pressure spikes (Table 1). Of the patients that experienced a pressure spike after surgery, the peak intraocular pressure was above 30 mmHg in most patients (Table 2) and was above 50 mmHg in seven placebo-treated patients and one IOPIDINE 1% Ophthalmic Solution-treated patient.

Table 1
Incidence of Intraocular Pressure Spikes Greater Than or Equal to 10 mmHg

Study Laser Procedure Treatment
Apraclonidine Placebo
P-Value aN (%) aN (%)
1 Trabeculoplasty <0.05 0/40 (0%) 6/35 (17%)
2 Trabeculoplasty =0.06 2/41 (5%) 8/42 (19%)
1 Iridotomy <0.05 0/11 (0%) 4/10 (40%)
2 Iridotomy =0.05 0/17 (0%) 4/19 (21%)
1 Nd:YAG Capsulotomy <0.05 3/80 (4%) 19/83 (23%)
2 Nd:YAG Capsulotomy <0.05 0/83 (0%) 22/81 (27%)
aN = Number Spikes/Number Eyes.

Table 2
Magnitude of Post-surgical Intraocular Pressure in Trabeculoplasty, Iridotomy and Nd:YAG Capsulotomy Patients With Severe Pressure Spikes Greater Than or Equal to 10 mmHg

Maximum Postsurgical Intraocular Pressure (mmHg)

Treatment Total Spikes 20-29 mmHg 30-39 mmHg 40-49 mmHg >50 mmHg
IOPIDINE 8 1 4 2 1
Placebo 78 16 47 8 7

Medication Guide


Apraclonidine can cause dizziness and somnolence. Patients who engage in hazardous activities requiring mental alertness should be warned of the potential for a decrease in mental alertness on the day of surgery.

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